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Third-Party Manufacturing Concerns Draw Complete Response for Navidea’s Lymphoseek

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The FDA has sent Navidea a complete response letter (CRL) on its Lymphoseek injection, citing concerns over quality control at third-party contract manufacturing facilities. The CRL followed an FDA inspection of those facilities and was not related to any safety or efficacy issues with Lymphoseek (technetium Tc 99m tilmanocept), the company added. It did not provide details about the good manufacturing practice issues raised in the letter.
Drug Industry Daily